Pharmacoepidemiology Analyst Full Time Permanent

1. Analytical Expertise

• Provide analytical expertise in support of pharmacoepidemiology studies, including risk management plans, studies that address regulatory safety questions or evaluate potential safety signals, and active surveillance studies

• Collaborate with Epidemiologists and Statisticians in study conceptualization and design, providing resource structure expertise to ensure feasibility of epidemiology and statistical specifications.

• Develop, execute, and validate logic to analytical results supporting pharmacoepidemiology studies.

• Provide technical support in the utilization of key statistical measures within analyses.

• Participate in team discussions regarding study output.

2. Internal authority on the use and contents of Large Healthcare Databases

• Develop an in-depth understanding of the variables and idiosyncrasies of in-licensed LHDs.

• Evaluate additional LHDs for potential licensing or other use.

• Identify opportunities to improve process efficiency and /or use of standards with analytical methods.

• Stay abreast of the latest technology and methods for analysis and use of LHDs.

• Ensure compliance with all applicable licenses and company guidelines regarding access and distribution of data, testing and validation practices, and documentation with regard to the utilization of LHDs

3. Analytical Tool Development

• Provide technical support for evaluation, development, implementation and training of analytical tools or technologies that support risk management, safety and surveillance activities.

• Network with appropriate colleagues (i.e., IT, Stats, etc.) to identify and implement consistent solutions.

• Assess updates to tools and technologies for evaluation of potential process enhancements

4. Collaborate with internal and external business partners

• Collaborate/consult with internal and external business partners to accomplish pharmacoepidemiology activities.

• Actively share expertise and knowledge regarding processes, tools and technology for pharmacoepidemiology.

• Communicate effectively with internal and external business partners.

5. Project Management

• Track timelines and resource needs for Research Analyst responsibilities of individual or team projects.

• Communicate updates including work status, schedule/conflicts, resource needs, risks and contingencies to management and as appropriate to core AS teams.

• Ensure the appropriate level of quality (i.e. compliance to corporate/local procedures, peer and technical reviews, etc.) are applied to all programming and validation deliverables

• As appropriate, engage with industry and other external forums and partnerships to: stay informed of impactful industry and technological developments, influence and share best practices, enhance understanding of new and existing analytic methods and LHDs

Confidential Minimum Qualification Requirements:

▪ A bachelor’s degree or higher, preferably in a health-related, statistical or information related field (e.g., epidemiology, statistics, information science, etc.)

▪ Excellent problem solving and analytic skills including 3+ years’ experience with statistical software packages.

▪ Excellent oral and written communication skills, particularly communicating and understanding technical information with diverse groups and individuals.

▪ Experience utilizing databases containing healthcare information. Other Information/Additional Preferences:

▪ Familiarity with Corporate Computer System Quality and other applicable policies and procedures.

▪ Competent in the analysis of data for clinical and epidemiological studies.

▪ High-level knowledge of global regulations for adverse event reporting and patient safety.

▪ Working knowledge of therapy and medical disease coding,

▪ Understanding of medical studies and medical research.

▪ Experience with data mining